dijous, 22 de gener del 2015

FDA warns against pediatric use of bone growth proteins




The FDA warns against using bone-growth proteins in patients under 18 who have bone growth defects, citing the risk of excess bone growth and other potential problems.






The FDA this week warned healthcare providers against using 2 types of bone-growth materials in patients under age 18 who have bone growth defects.




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Study finds huge price gaps for hip, knee surgeries




A study by Blue Cross Blue Shield finds huge disparities in the pricing for hip and knee replacement surgeries.






(Reuters) — Hip and knee replacements, 2 of the fastest-growing U.S. medical procedures, are subject to huge – and apparently random – price variations within the same geographical areas, a new insurance industry study said yesterday.




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A CDRH Priority: Clinical Trials in the U.S.




FDA's official blog brought to you from FDA's senior leadership and staff stationed at home and abroad – sharing news, background, announcements and other information about the work done at the FDA on behalf of the American public.






Owen Faris

Owen Faris, Ph.D., Clinical Trials Director (acting), Office of Device Evaluation in FDA's Center for Devices and Radiological Health


By Owen Faris, Ph.D., and Jeffrey Shuren, M.D., J.D.


At the Center for Devices and Radiological Health (CDRH), clinical trials are the foundation for our decisions to approve the most important medical devices—products that have the potential to save or sustain life, but that also present the greatest risk to patients.




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Ocular Therapeutix launches dry-eye trial




Ocular Therapeutix launches a Phase II study to test its bioresorbable eye-plug in treating inflammatory dry-eye disease.








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Opto Circuits' Eurocor wins CE Mark for drug-eluting stent




Eurocor, a subsidiary of India's Opto-Circuits, wins CE Mark approval in the European Union for its E-Magic Plus sirolimus-eluting coronary stent.






Eurocor said it gained CE Mark approval in the European Union for its new drug-eluting stent made with a biodegradable polymer.




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Covidien's Q1 earnings top estimates




Covidien issues its final quarterly report as a standalone company, saying its fiscal 1st-quarter earnings beat expectations and it prepares for a $43 billion acquisition by Medtronic next week.








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CareFusion shareholders OK $12B BD buyout




CareFusion's shareholders OK its proposed $12 billion merger with Becton Dickinson.








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